HDMA - Healthcare Distribution Management Association

03/05/2026 | Press release | Distributed by Public on 03/05/2026 09:56

HDA Statement on FDA’s 12-digit National Drug Code Final Rule

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HDA Statement on FDA's 12-digit National Drug Code Final Rule

March 05, 2026

The Healthcare Distribution Alliance (HDA) released the following statement on the U.S. Food and Drug Administration's final rule expanding the National Drug Code (NDC) to a 12-digit format:

"HDA appreciates the FDA's work to modernize the NDC system and address long-standing concerns about NDC exhaustion. We have been engaging with the agency throughout the rulemaking process and support the underlying goal of ensuring the NDC framework remains sustainable for the future.

"As healthcare distributors, our members play a central role in moving medicines safely and efficiently across the supply chain. Because the NDC is embedded in ordering, billing, reimbursement, traceability and compliance systems nationwide, thoughtful implementation is critical to avoiding unintended disruptions for manufacturers, pharmacies, providers, payers and, most importantly, patients.

"We look forward to carefully reviewing the final rule and continuing to work with FDA and other federal partners to support a coordinated, transparent transition. HDA remains committed to collaborating with regulators and stakeholders to implement this change in a way that strengthens the healthcare supply chain and patient access to medications."

About HDA

The Healthcare Distribution Alliance (HDA) represents primary pharmaceutical distributors - the vital link between the nation's pharmaceutical manufacturers and pharmacies, hospitals, long-term care facilities, clinics and others nationwide. Since 1876, HDA has helped members navigate regulations and innovations to get the right medicines to the right patients at the right time, safely and efficiently. The HDA Research Foundation, HDA's nonprofit charitable foundation, serves the healthcare industry by providing research and education focused on priority healthcare supply chain issues.

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